Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

Qaashif Panjwani, Mercer University College of Pharmacy

Commonly utilized percutaneous interventions (PCI)  are stated to be drug-eluting and bare-metal stents. [1] A meta-analysis on PCIs indicated no statistical differences among drug-eluting and bare-metal stents in reducing total mortality and proposed a need for long-term follow up to better assess specific safety concerns of the stents. [2]

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease [3]
Design Multicenter, randomized trial; N= 9,013
Objective To determine the rates of death, myocardial infarction (MI), repeat revascularization, and stent thrombosis in long-term use of drug-eluting stents versus bare-metal stents
Study Groups Drug-eluting stent (n= 4,504); bare-metal stent (n= 4,509)
Methods The patients included in the trial were at least 18 years of age and had stable angina, acute coronary syndrome, lesions in native coronary arteries, or coronary-artery grafts. Patients were assigned to each of the respective stents at a 1:1 ratio. All the patients were prescribed aspirin 75 mg daily indefinitely and clopidogrel 75 mg for 9 months. A quality-of-life questionnaire was submitted to the patients at baseline then at 6, 12, 24, 36, 48, and 60 months. The median follow-up was 5 years.
Duration 6 years
Primary Outcome Measure A composite of death from any cause and nonfatal spontaneous myocardial infarction
Baseline Characteristics
  Drug-eluting stent Bare-metal stent
Mean age (years) 62.6 62.6
Male n, (%) 3377 (75.0) 3380 (75.0)
Medical history n, (%)
Diabetes mellitus 575 (12.8) 548 (12.2)
Hypertension 1934 (42.9) 1857 (41.2)
Hypercholesterolemia 2413 (53.6) 2455 (54.4)
Previous MI 433 (9.6) 479 (10.6)
Previous stroke 177 (3.9) 169 (3.7)
Previous coronary-artery bypass graft 293 (6.5) 300 (6.7)
Results  

  Drug-eluting stent Bare-metal stent Hazard ratio p-value
Primary Outcome n, (%) 643 (16.6) 656 (17.1) 0.98 0.66
Nonfatal spontaneous MI n, (%) 356 (9.8) 399 (10.5) 0.89 0.10
Death from any cause n, (%) 287 (7.5) 257 (7.4) 1.11 0.21
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions There were no statistically significant differences in the 6-year rates of death or spontaneous MI patients receiving drug-eluting stents or bare-metal stents.

This study is one of the longer follow-up trials examining the long-term efficacy of each of the respective stents. In future studies, it would be beneficial to account for costs associated with adverse events to help decide on a stent. From a clinical standpoint, further evidence would assist in deciding on a stent. Lastly, the Seattle Angina Questionnaire was utilized to collect quality-of-life data, which is not specific for stent performance and as a result causes a loss of generalizability.

 

References

  1. Prasad A, Herrmann J. Myocardial infarction due to percutaneous coronary intervention. N Engl J Med. 2011;364(5):453-64.
  2. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J. 2006;27(23):2784-814.
  3. Bønaa KH, Mannsverk J, Wiseth R, et al. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016;
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